Determiner Pl/Determination of Phospholipids
FDA 510(k) K905829 · Kamiya Biomedical Co.
510(k) numberK905829
Submission
- Device name
- Determiner Pl/Determination of Phospholipids
- Applicant
- Kamiya Biomedical Co.
Thousand Oaks, CA, US - Received
- December 31, 1990
- Decision date
- January 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEL – Ammonium Molybdate And Ammonium Vanadate, Phospholipids
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1575
- Specialty
- Clinical Chemistry
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Questions and answers
When was Determiner Pl/Determination of Phospholipids cleared by the FDA?
Determiner Pl/Determination of Phospholipids (K905829) received a 510(k) decision of Substantially Equivalent on January 30, 1991, 30 days after the submission was received.
What is the product code of K905829?
The FDA product code is CEL – Ammonium Molybdate And Ammonium Vanadate, Phospholipids, a Class I (low risk) device regulated under 21 CFR 862.1575.